Easydew Daily Fresh Mild Sun by DN Company Co., Ltd. / Cosmax, Inc.

Easydew Daily Fresh Mild Sun by

Drug Labeling and Warnings

Easydew Daily Fresh Mild Sun by is a Otc medication manufactured, distributed, or labeled by DN Company Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EASYDEW DAILY FRESH MILD SUN- octinoxate, titanium dioxide, avobenzone, octisalate, octocrylene cream 
DN Company Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredient: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.2%, Butyl Methoxydibenzoylmethane 2.5%, Ethylhexyl Salicylate 2.0%, Octocrylene 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Ethylhexyl Palmitate, Cyclopentasiloxane, Butylene Glycol, 4-Methylbenzylidene Camphor, Dipropylene Glycol, Cetearyl Alcohol, Glyceryl Stearate, Polysorbate 60, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Methyl Methacrylate Crosspolymer, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Caprylate, Beeswax, Phenoxyethanol, Fragrance(Parfum), Caprylyl Glycol, Dimethicone, Caprylic/Capric Triglyceride, Alcohol, Xanthan Gum, Disodium EDTA, 1,2-Hexanediol, Hydrogenated Lecithin, Propylene Glycol, Hydrogenated Phosphatidylcholine, Alcohol Denat., Sodium Stearoyl Glutamate, Ceramide 3, Cholesterol, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Pinus Pumilio Bark Extract, Poterium Officinale Root Extract, Veronica Officinalis Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Keep out of reach of children. Avoid contact with eyes. If eye contact occurs, rinse immediately with water and if it is necessary, contact an ophthalmologist. Discontinue use if signs of irritation and/or rash appear. Keep in a cool and dry place.

DESCRIPTION

Use: Help prevent sunburn. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions: At the last stage of your skincare routine, evenly apply onto face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY FRESH MILD SUN 
octinoxate, titanium dioxide, avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 g  in 60 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.2 g  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.2 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-130-02	1 in 1 CARTON	07/15/2016	11/01/2019
1	NDC: 60565-130-01	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/15/2016	11/01/2019

Labeler - DN Company Co., Ltd. (688369859)

Registrant - DN Company Co., Ltd. (688369859)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-130)

Revised: 12/2019

Document Id: 63a89b2c-4168-43d5-ac5f-c312f66f2217

34390-5

Set id: 5da28f30-5ed6-4234-a417-0c544bf061de

Version: 3

Effective Time: 20191231

 

DN Company Co., Ltd.